Slow breathing and ear nerve stimulation added to depression care in hospital patients
Tests slow breathing and ear stimulation alongside usual care in hospitalized adults with depression.
Plain-language title generated from the registry record
Registry title: Slow-Paced Breathing and Electrical Vagus Nerve Stimulation as Add-on Treatments for Depression
Key facts
- Where
- Meiringen, SwitzerlandSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07844733, who can take part
Where in Switzerland
- Privatklinik MeiringenMeiringen, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Elisabeth Balint
- Trial code
- NCT07844733
- Record updated
- 2 October 2026
- Original description
Depression is a common mental health condition, and standard psychiatric therapies do not always lead to satisfactory recovery. As a result, there is an urgent need for effective, complementary treatments.Read full original descriptionShow less
Add-on Therapy of Depression Using Vagus Nerve Stimulation
Depression is a common mental health condition, and standard psychiatric therapies do not always lead to satisfactory recovery. As a result, there is an urgent need for effective, complementary treatments.
The vagus nerve is the main component of the parasympathetic nervous system, which regulates bodily rest and calms inflammatory responses. In clinical depression, vagus nerve activity is often reduced, and low-grade inflammation is frequently observed. While electrical stimulation of the vagus nerve via surgically implanted devices has been shown to reduce depressive symptoms, its invasive nature carries risks. Non-invasive alternatives-such as slow-paced breathing exercises or gentle transcutaneous electrical stimulation at the outer ear-offer promising ways to stimulate this nerve safely without surgery.
The main purpose of this clinical study is to evaluate whether slow-paced breathing is an effective add-on therapy to reduce depressive symptoms in hospitalized patients compared to standard multimodal psychiatric treatment. Additionally, the study investigates whether the effects of slow-paced breathing are comparable to transcutaneous auricular vagus nerve stimulation (tVNS) and whether they differ from a sham (placebo) stimulation.
A total of 160 adult inpatients with at least a moderate depressive episode will be randomly assigned to one of four groups during their hospital stay:
Group 1 (Slow-Paced Breathing): Participants practice a guided, slow-paced breathing technique (inhaling for 4 seconds, exhaling for 6 seconds) for 20 minutes, 3 times daily, 5 days per week over 4 weeks.
Group 2 (Electrical Vagus Nerve Stimulation): Participants receive non-invasive electrical stimulation to the outer ear canal using a certified medical device (tVNS) for 20 minutes, 3 times daily, 5 days per week over 4 weeks.
Group 3 (Sham Stimulation): Participants receive identical-looking electrical stimulation applied to the earlobe (an area lacking vagal nerve fibers) on the same schedule, serving as an active control. Participants do not know whether they receive active or sham stimulation.
Group 4 (Treatment as Usual): Participants receive the standard multimodal inpatient psychiatric treatment program alone, alongside daily logging of relaxation and mindfulness activities.
All participants continue to receive standard psychiatric care. Depressive symptoms are assessed using the Beck Depression Inventory-II (BDI-II) and the Hamilton Depression Rating Scale. In addition, heart rate variability (HRV) via a 24-hour recording and blood inflammatory markers (such as IL-6 and CRP) are measured before and after the 4-week intervention period to explore the physiological mechanisms of vagus activation. A follow-up questionnaire is completed after 3 months to assess long-term outcomes.
Inclusion: Inpatient psychiatric admission at Privatklinik Meiringen; Clinical primary diagnosis of at least a moderate depressive episode; Beck Depression Inventory-II (BDI-II) score of at least 20 at admission; Age between 18 and 60 years; Written informed consent prior to study participation; Ability to understand the study procedures and give informed consent.
Exclusion: Current treatment with, or planned administration during the hospital stay of, ketamine or electroconvulsive therapy (ECT); Active substance use disorder / addiction; Bipolar disorder; Borderline personality disorder; Current malignancy; Presence of a cardiac pacemaker; Current psychosis; Multiple sclerosis; Known or confirmed pregnancy; Body Mass Index (BMI) greater than 35 kg/m².